Par Pharmaceutical Companies, Inc. has entered into an exclusive licensing agreement under which Par will receive commercialization rights in the US to BioAlliance Pharma's Loramyc an innovative antifungal therapy currently, in phase III development for the treatment of oropharyngeal candidiasis, an opportunistic infection commonly found in immuno compromised patients, including those with HIV and cancer.
Under the agreement, BioAlliance will receive an initial payment of $15 million. Par will also pay BioAlliance $20 million upon FDA approval. In addition to royalties on sales, BioAlliance may receive milestone payments on future sales.
Loramyc, which received marketing authorization in France in October 2006, is an antifungal delivered in a mucoadhesive buccal tablet, enabling an early and extended release of the active ingredient at the site of the infection, with once-daily dosing.
The ongoing pivotal phase III trial for Loramyc involves 540 patients at 40 sites in the US, Canada and South Africa.
John A MacPhee, president of Par's branded products division, said, "We believe our collaboration with BioAlliance will lead to an important treatment option. It also advances Par's strategy to build a portfolio specifically addressing supportive care, and we will continue to look for additional products that leverage our existing commercial presence in specialty markets."
Dominique Costantini, CEO of BioAlliance said, "Par is the ideal partner for Loramyc commercialisation in the US, with a sales force dedicated to supportive care and a product portfolio in which Loramyc will represent an important addition. This major milestone for patients and the medical community is also an important step for our company and its shareholders, delivered in due time."